System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance

Gregory Martin

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Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended.

This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results.

Objectives of the Presentation

  •  Understand the FDA and USP Requirements for System Suitability Testing
  • Learn which parameters should be included in SST, and how they relate to USP General Chapter <621>
  • Understand how SST, Instrument Qualification and Quality Controls are related, and how they are different
  • Learn what to do if your method fails to meet SST requirements

Areas Covered

  • FDA and USP Requirements for System Suitability Testing (SST)
  • System Suitability Testing as an integral part of Analytical Control Strategy
  • Which Parameters should be included in SST?
  • How does SST relate to USP <621> Chromatography
  • What if you fail the SST criteria?
  • Understanding the relationship among SST, Instrument Qualification and Quality Control Samples
  • Recommendations for non-chromatographic methods
  • Attendee Questions

Target Audience

Chemists (Research, Quality Control, and CRO; Human, Veterinary, Generic or Dietary Supplements) involved with dissolution method development or testing and their managers, QA personnel responsible for reviewing investigations, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution, Laboratory managers and supervisors , Quality Assurance Managers , GMP auditors ,Consultants.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

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Recorded video

Recorded video session

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Speaker: Gregory Martin,

Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance